title: Safety of BLP25 liposome vaccine (L-BLP25) in Japanese patients with unresectable stage III NSCLC after primary chemoradiotherapy: preliminary results from a Phase I/II study.
abstract: Preliminary safety findings are presented from the open-label Phase I part of a combined Phase I/II study of BLP25 liposome vaccine (L-BLP25) in Japanese patients with unresectable Stage III non-small-cell lung cancer after primary chemoradiotherapy. Six patients received four or more once-weekly vaccinations with L-BLP25 1000 μg subcutaneously prior to a preliminary safety evaluation. Treatment continued with once-weekly vaccinations with L-BLP25 1000 μg subcutaneously until week 8, then maintenance vaccinations every 6 weeks until progressive disease. Cyclophosphamide (300 mg/m(2) i.v. single dose) was given 3 days before first vaccination. Median age was 63.5 years and performance status was 0-1. No serious adverse events occurred; none necessitated discontinuation. L-BLP25-related adverse events (Grade 1) were myalgia, arthralgia and nausea; cyclophosphamide-related adverse events comprised dysgeusia, anorexia and nausea. The first evaluation of L-BLP25 in Japanese patients shows that it is well tolerated, and the safety profile is consistent with that seen in previous studies of Caucasian patients.
authors.affiliation: The Cancer Institute Hospital of JFCR, 3-10-6 Ariake, Koto-ku, Tokyo 135-8550, Japan.
authors.forename: Fumiyoshi
authors.initials: F
authors.lastname: Ohyanagi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Horai
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
authors.forename: Stefanie
authors.initials: S
authors.lastname: Senger
authors.forename: Nassim
authors.initials: N
authors.lastname: Morsli
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D018771:Arthralgia / Q000139:chemically induced; D044466:Asian People; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000517:prevention & control* / Q000532:radiotherapy; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000517:prevention & control* / Q000532:radiotherapy; D008297:Male; D008562:Membrane Glycoproteins / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D019496:Cancer Vaccines; C518273:L-BLP25; D008562:Membrane Glycoproteins